Further information

Course "Biostatistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Why should you attend:

Statistics is a useful decision-making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical software’s are now available to professionals. However, these software’s were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.

Who will benefit:

Physicians

Clinical Research Associates

Clinical Project Managers/Leaders

Sponsors

Regulatory Professionals who use statistical concepts/terminology in reporting

Medical Writers who need to interpret statistical reports

Day 1 Schedule

Lecture 1 (90 Mins):

Why Statistics?

Do we really need statistical tests?

Sample vs. Population

I'm a statistician not a magician! What statistics can and can't do

Descriptive statistics and measures of variability

Lecture 2 (90 Mins):

The many ways of interpretation

Confidence intervals

p-values

effect sizes

Clinical vs. meaningful significance

Lecture 3 (90 Mins):

Common Statistical Tests

Comparative tests

Regression analysis

Non-parametric techniques

Lecture 4 (90 Mins):

Bayesian Logic

A different way of thinking

Bayesian methods and statistical significance

Bayesian applications to diagnostics testing

Bayesian applications to genetics

Day 2 Schedule

Lecture 1 (90 Mins):

Interpreting Statistics – Team Exercise

Team Exercise: Review a scientific paper and learn how to

Interpret statistical jargon

Look for reproducibility, transparency, bias, and limitations

Convey information coherently to non-statisticians

Lecture 2 (90 Mins):

Study power and sample size

Review of p-value, significance level, effect size

Formulas, software, and other resources for computing a sample size

Lecture 3 (90 Mins):

Developing a Statistical Analysis Plan

Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).

An SAP template will be given to all attendees.

Lecture 4 (90 Mins):

Specialized topics/Closing Comments/Q&A

Comparing Survival Curves

Pharmocokinetics/Pharmacodynamics (PK/PD)

Taking a holistic view to study design and interpretation

Question and Answer session

Speaker

Elaine Eisenbeisz

Owner and Principal Statistician, Omega Statistics

Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.

In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.

Further information

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